Douglas Pharmaceuticals Announces Formation of Clinical Advisory Board for Lead Program R-107

AUCKLAND, New Zealand, Jan. 26, 2023 /PRNewswire/ -- Douglas Pharmaceuticals, a New Zealand Pharmaceutical company focused on specialty generic and repurposed drug development, today announced the formation of a clinical advisory board to support its lead program R-107, an oral extended-release dose of racemic ketamine being developed as add-on or monotherapy for treatment resistant depression (TRD).

"We are very excited to bring together a group of world-class experts in the field of psychiatry, to help guide our late-stage development of R-107," said Peter Surman, Chief Scientific Officer. "We believe their deep knowledge in the field, insights and contributions will be instrumental in charting an efficient course through pivotal clinical studies in TRD."

The members of the clinical advisory board include:

• Prof. Paul Glue, MB, ChB (Otago), MD (Bristol), FRCPsych – Dr. Paul Glue is the Hazel Buckland Professor of Psychiatry at the University of Otago, New Zealand and Chair of Douglas' R-107 Trial Steering Committee. He joins in the role of Board Chair with extensive experience in psychiatric research in ketamine, including early development of R-107. His areas of interest include the pharmacology of drug treatments in psychiatry and the investigation of disease mechanisms in neurological and psychiatric disorders. He has published extensively in the fields above, with more than 250 papers and book chapters to his name.
• Prof. Alan F. Schatzberg, MD – Dr. Alan F. Schatzberg is the Kenneth T. Norris, Jr. Professor of Psychiatry & Behavioural Sciences at Stanford University, US. From 1991-2010, he was the Chair of the Department at Stanford. He is also the Director of the Stanford Mood Disorders Center and Emeritus Editor for Journal of Psychiatric Research. Dr. Schatzberg's current research interests include the biological bases of depressive disorders, glucocorticoid/dopamine interactions in delusional depression and pharmacologic treatment of depressive disorders, with more than 400 publications to date. Dr. Schatzberg has been extensively involved as investigator in several trials in depressive disorders. He was elected the 136^th President of the American Psychiatric Association and is a member of the National Academy of Medicine.
• Prof. Sanjay J. Mathew, MD – Dr. Sanjay J. Mathew is a Professor of Psychiatry and Behavioural Sciences, Vice Chair for Research and Director of Mood and Anxiety Disorders Program at Baylor College of Medicine, Texas, USA. His clinical expertise is in the psychopharmacological management of adult patients with difficult-to-treat depressive and anxiety disorders. He has been the recipient of several grants related to his research in the neurobiology treatment of depressive disorders and authored over 150 manuscripts.
• Prof. Allan Young, MB, ChB, MPhil, PhD, FRCP (Edin.), FRCPC, FRCPsych – Dr. Allan Young is Professor of Mood Disorders and is the Director of the Centre for Affective Disorders in the Department of Psychological Medicine in the Institute of Psychiatry, Psychology and Neuroscience as well as Head of School and Vice-Dean for Academic Psychiatry at King's College London, UK. Dr. Young is the National Institute for Health Research (NIHR) Mental Health Biomedical Research Centre (BRC) Cluster and Theme lead in the Translational Therapeutics Cluster. He is the clinical academic lead in the Psychological Medicine and Integrated Care Clinical Academic Group in the South London and Maudsley NHS Trust where he is also a Consultant Psychiatrist and the head of the National Affective Disorders Tertiary Clinic. Dr. Young's research interests focus on the cause and treatments for severe psychiatric illnesses, particularly mood disorders. He is ranked as one of the world's leading scientific minds according to the Thomson Reuters Highly Cited Researchers list, ranking among the top 1% most cited for their subject field and year of publication, a mark of exceptional impact.
• Prof. Wiesław J. Cubała, MD, PhD – Dr. Wiesław J. Cubała is the Head of the Department of Psychiatry at the Medical University of Gdansk, Poland. His research interests focus on the psychopharmacology of mood disorders with a particular interest in ketamine/esketamine/arketamine use in major depression and bipolar disorder as well as clozapine use in treatment-resistant bipolar depression with a focus on suicidality and its rapid-cycling course. Dr. Cubała is engaged in the development of the national treatment guidelines for mood and anxiety disorders. He is also the author of over 160 publications in depressive disorders and was an editorial board member of BJPsych Open and European Neuropsychopharmacology: the journal of the European College of Neuropsychopharmacology in 2021. Dr. Cubała has been extensively involved as investigator in several trials in mood disorders including 14 trials with Rapid-Acting Antidepressants to date.
• Prof. Colleen Loo, MBBS (Hons), FRANZCP, MD –Dr. Colleen Loo is Professor of Psychiatry at the University of New South Wales, Sydney and Professor and leader of the Neurostimulation and Interventional Psychiatry program at the Black Dog Institute, Sydney, Australia. Her research interests focus on improving treatments for treatment-resistant depression, including electroconvulsive therapy (ECT), Transcranial Magnetic Stimulation (TMS), transcranial Direct Current Stimulation (tDCS) and ketamine. She was president of the International Society for ECT and Neurostimulation from 2018-2020. From 2011, she conducted a series of studies on ketamine treatment of depression, examining different routes of administration, dosing approaches and developing a system for safety monitoring. She has published over 300 peer reviewed papers and contributed to national and international guidelines.

For further information, please contact:

Stephen Waterman
Managing Director
PharmaVentures Ltd
stephen@pharmaventures.com
+44-7931144097

About Douglas Pharmaceuticals

Douglas Pharmaceuticals is New Zealand's largest privately owned pharmaceutical and healthcare company. It was founded in 1967 by pharmacist Sir Graeme Douglas and today employs over 700 people and exports to over 40 countries around the world.

The Douglas mission is to 'Improve Lives' by providing innovative, competitive, and high-quality healthcare solutions. Douglas' core business is producing prescription drugs for areas including oncology, dermatology, the central nervous system, and immunology. Douglas develops, manufactures, and distributes novel and generic products, with a preference for those where there is a strong intellectual property position as well as technical complexity in areas of high unmet need. 

Furthermore, as of Sep 2022 a state-of-the-art research and development facility has opened in West Auckland, which aims to use world class medical research to find solutions for a range of serious illnesses. The $50MM Douglas Innovation centre is part of the long-established Douglas campus in Auckland. The three story, 4,500sq metre building was 18 months in construction. It employs 100 people and includes laboratory, pilot scale product development suites, commercial manufacturing rooms which can handle highly potent and cytotoxic products, and office space. Manufacturing capabilities include soft gelatine encapsulation, liquids, creams, and modified release oral dosage forms.

For more information, please visit: www.douglas.co.nz

R-107

R-107, an oral extended-release dose of racemic ketamine being developed as add-on or monotherapy for treatment resistant depression (TRD). Phase 2 results demonstrated a significant antidepressant effect within 8 days, dose-dependent sustained mood improvement, with maintenance of response at 3 months, high compliance at-home dosing regimen. R-107's robust safety profile is enabled by a proprietary oral extended-release tablet, which has been formulated with abuse-deterrent features. R-107 has potential for expedited regulatory pathway in the US and EU, with potential market entry as early as 2026 and a strong IP protection in place through to at least 2037 excluding potential extensions. Douglas has also collected positive responses to the R-107 Target Product Profile from Key Opinion Leaders and payers in US & EU.